1. Field of the Invention
The present invention relates to an implant for pelvic organ prolapse support. More specifically, the present invention relates to an implant that is capable of simultaneously supporting bladder, urethra, uterus, vaginal vault, intestine, rectum, and anus in female patients with pelvic organ prolapse.
2. The Prior Arts
Throughout women's lifespan, the incidence of pelvic organ prolapse (POP) is close to 50%. Approximately one tenth of the female population would receive surgeries associated with POP before age of eighty and about 30% of which may receive more than one surgery. Regarding the goal of pelvic reconstructive surgery, besides restoring organs to their normal anatomical positions, physicians also design the most appropriate surgery by taking account of urination symptom, age, physical condition, and sexual function of each patient.
It is known that the conventional pelvic reconstructive surgeries are not effective and sustainable with possibility of recurrence up to 30%. To improve such flaws, utilizing artificial mesh is the current trend and is indeed effective with regard to the short-term success rate. On the other hand, using mid-urethral sling made of artificial mesh for the treatment of stress urinary incontinence (SUI) has become a gold standard method. Clinically, if a patient has both cystocele and SUI, two artificial meshes are required to be used separately by surgery; if the patient also suffers from prolapse of other pelvic organs, even more artificial meshes are needed. Although the surgery using artificial mesh shows high success rate and is effective in terms of fixation, the effectiveness and safety of using artificial mesh in standard pelvic reconstructive surgery are still questionable and require further investigation.
Over the past few years, Food and Drug Administration of the United States constantly receives reports regarding adverse reactions of artificial meshes. More than 1,000 adverse reaction cases of using artificial mesh for the treatment of POP and SUI were reported between 2005 and 2007. In 2008 alone, 2,874 cases of adverse reaction with 3 deaths were reported. Common adverse reactions reported include: mesh extrusion, infection, pain, difficulties during sexual activity, pain during sexual activity, vaginal scar, urinary retention, or recurrence of POP or SUI. Hence, Food and Drug Administration of the United States had sent out warnings regarding the use of artificial mesh in October 2008, which indicated the possibility of severe complications caused by using artificial mesh for the treatment of POP and SUI.
As a result, for the treatment of POP and SUI, the search for alternative therapies as well as improvement of the current artificial mesh by utilizing the advantages of the good supportive characteristics and high surgical success rate thereof to conquer or overcome the possibility of complications are needed.